Visionaire: A Prospective Study
Primary Purpose
Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visionaire system (Knee MRI)
No Knee MRI
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis focused on measuring Total knee arthroplasty (TKA), Computer aided systems
Eligibility Criteria
Inclusion Criteria:
- Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA
Exclusion Criteria:
- prior TKA
- ipsilateral upper tibial or distal femoral osteotomy
- ipsilateral total hip arthroplasty
- patient with significant >15o varus or valgus
- morbid obesity or those patients unable to have an MRI based on thigh circumference (22 cm or less)
Sites / Locations
- Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Computer-aided TKA
Conventional TKA
Arm Description
The Visionaire system is a computer-aided system utilizing MRI of the knee prior to TKA surgeries. This technology achieves accurate rotational and A-P position. All of the commonly-referred anatomical landmarks (AP axis, epicondylar axis) are analyzed pre-operatively, allowing for the proper positioning of the implant for each patient.
A conventional TKA utilizes a jig system based on either intra-medullary or extra-medullary guides. No knee MRI is utilized for a conventional TKA.
Outcomes
Primary Outcome Measures
Knee Society Score
Secondary Outcome Measures
Degrees off normal AP and lateral alignment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01937572
Brief Title
Visionaire: A Prospective Study
Official Title
Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
An interim analysis found the study would not be able to reach significance without a large increase in subjects which was not feasible.
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hawkins Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system.
It is hypothesized that there will be no significant differences in position, loosening, or function of the Visionaire total knee as compared to the conventional total knee.
It is hypothesized that the Visionaire total knee will be significantly better with regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover time, and overall costs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Total knee arthroplasty (TKA), Computer aided systems
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computer-aided TKA
Arm Type
Experimental
Arm Description
The Visionaire system is a computer-aided system utilizing MRI of the knee prior to TKA surgeries. This technology achieves accurate rotational and A-P position. All of the commonly-referred anatomical landmarks (AP axis, epicondylar axis) are analyzed pre-operatively, allowing for the proper positioning of the implant for each patient.
Arm Title
Conventional TKA
Arm Type
Other
Arm Description
A conventional TKA utilizes a jig system based on either intra-medullary or extra-medullary guides. No knee MRI is utilized for a conventional TKA.
Intervention Type
Other
Intervention Name(s)
Visionaire system (Knee MRI)
Other Intervention Name(s)
Visionaire
Intervention Type
Other
Intervention Name(s)
No Knee MRI
Primary Outcome Measure Information:
Title
Knee Society Score
Time Frame
one year
Secondary Outcome Measure Information:
Title
Degrees off normal AP and lateral alignment
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Total blood loss
Time Frame
two days
Title
Operative time
Time Frame
one day
Title
Operative room setup and turnover times
Time Frame
one day
Title
Procedural cost
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA
Exclusion Criteria:
prior TKA
ipsilateral upper tibial or distal femoral osteotomy
ipsilateral total hip arthroplasty
patient with significant >15o varus or valgus
morbid obesity or those patients unable to have an MRI based on thigh circumference (22 cm or less)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Burnikel, MD
Organizational Affiliation
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
12. IPD Sharing Statement
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Visionaire: A Prospective Study
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